A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) or Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 2
- 主要终点
- Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects of any race, ages 18-75 inclusive
- •Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD
- •The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1)
- •Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥ 24 and corresponding to a CGI S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2)
- •The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis
- •Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning
- •Able to provide written informed consent
排除标准
- •Any female subject who is pregnant or breast-feeding
- •Any subject judged to be medically inappropriate for study participation
- •The patient has a significant risk for suicidal behavior
- •The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma
研究组 & 干预措施
Lumateperone 42mg
Lumateperone 42mg administered once daily in the evening
干预措施: Lumateperone (Drug)
Placebo
Matching placebo administered once daily in the evening
干预措施: Placebos (Drug)
结局指标
主要结局
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
时间窗: Day 43
The Montgomery-Åsberg Depression Rating Scale is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
次要结局
- Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)(Day 43)